Kornimate/medical-research-clean huggingface dataset:
international liver surgery outcomes study

Conditions: Liver Diseases

Summary: this study was to designed to measure the true worldwide practice of liver surgery and associated outcomes by recruiting multiple international centres, committing to consecutive patient registration per surgeon and undergo rigorous data validation. it is hoped that these data will provide a more appropriate guide to inform surgeons and patients to assess which level of complexity should be routinely offered for high tumour burden and anatomically difficult scenarios.

liver surgery was associated with at least 10% mortality in the 1970's. the safety of liver surgery has dramatically improved since with a mortality of now around 1-2%. individual centres postulate that a perioperative mortality close to 0% should be the standard of major liver resection. despite these claims, epidemiological studies showed a mortality rate of 6%. outcomes in liver surgery are likely influenced by indications, complexity, centre and surgeon skills, equipment, centre and surgeon experience. the aim of livergroup.org is to develop an international data set on the outcomes of liver resections among a large number of international surgeons. the 'collaborative' model for 'snapshot' clinical audit is now well established and such research is a novel approach for assessing current practice in a short period of time. the primary objective of the study is to provide a verified record of the true perioperative morbidity and mortality of a representative set of liver surgeons worldwide in 2019. secondary objectives include risk factors for mortality and morbidity using multivariable regression models. any surgeon performing liver resections is eligible to participate in livergroup.org. all consecutive cases will be included and there are no minimum patient numbers per centre. liver transplantation is excluded. there will be 3 months of prospective patient enrolment and 3 months follow up within the 12-month frame, january to december 2019. all liver resections, all indications, as well as all co-morbidities will be included. liver transplantation, imaging-guided ablations and liver biopsies are excluded.

Eligibility criteria:
inclusion criteria: * all indications (including benign and living donor resections) * all co-morbidities * open, laparoscopic or robotic * single wedge resections to extended liver resections * single or two-stage hepatectomies * procedures with liver volume enhancement such as pve, pvl, alpps. * resections involving cold perfusion (ex-situ and ante-situ) * there are no exclusion criteria as related to indication, age or comorbidities. exclusion criteria: * liver transplantation * imaging-guided liver ablation techniques alone * liver biopsies

Keywords: liver surgery outcomes snapshot collaborative international
daptomycin versus placebo in patients with neutropenia and fever

Conditions: Febrile Neutropenia

Summary: the purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.

to determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops is higher when daptomycin compared to placebo is added at the same time as anti gram-negative therapy. the five day time point is selected because it is at this point where it is recommended to add antifungal therapy to the treatment regimen if the patient is still febrile.

Eligibility criteria:
inclusion criteria: 1. patients in the above categories who are currently undergoing chemotherapy. 2. patients at least 18 of age. 3. patient expected to reach an absolute granulocyte count of \<100 cells/mm3 4. patients who have given written consent because of the above criteria must have at least one temperature of greater or equal to 38.3° or temperatures \> 38o on at least two occasions before study drug is administered. exclusion criteria: 1. patients with lymphoma or with solid tumor undergoing initial chemotherapy. their neutropenia is of insufficient duration for adequate test of the value of an anti-gram positive antibiotic. 2. patients undergoing auto-transplantation, for the same reason as above. 3. patients with evidence of a clinical infection such as presence of a pulmonary infiltrate by x-ray or clinical evidence for the presence of cellulitis. 4. patients who have received daptomycin in the two weeks prior to enrollment. 5. patients with concomitant use of vancomycin. 6. patients with creatinine clearance \ 3x normal 7. patients with significant hepatic dysfunction, defined as baseline liver function tests \> 5x above normal. 8. patients with known allergy to daptomycin. 9. patients previously in this study. 10. women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-hcg). 11. patients previously enrolled in this study.
study to evaluate long term performance and safety of the knee prosthesis (hls kneetec deep dish)

Conditions: Total Knee Arthroplasty; Knee Disease; Total Knee Replacement; Osteo Arthritis Knee

Summary: the aim of this study is to assess the long-term performance and safety of hls kneetec deep dish knee prosthesis when used in standard medical practice

it is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a single french site where total knee arthroplasty with hls kneetec deep dish prosthesis is performed routinely all patients treated with hls kneetec deep dish implant will be included. all eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study. patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up (fu) visits as following: 3 months (+/- 1 months); 15 months (+/- 3 months); 5 years (+/- 6 months) and 10 years (+/- 6 months).

Eligibility criteria:
inclusion criteria: * male or female aged 18 - 80 years old at the time of the surgery * implanted with an hls kneetec deep dish tkp according to the instructions for use (ifu) after the 1st of february, 2017 * patients agree to consent to collect data from their medical records and agree to answer questionnaires for the purposes of the study. exclusion criteria: * patients under guardianship and/or those who, according to the investigator or his delegated research team, will not be able to comply with the study procedures. (e.g. illiteracy, recent psychotic or manic disorders and/or inability to comply with routine follow-up visits.)

Keywords: knee arthroplasty prosthesis ultracongruent prosthesis implants hls implants arthroplasty
comorbidities in type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: type 2 diabetes mellitus (dm) has adopted a top priority as it is a disease with an increasing prevalence. the number of people living with dm has increased more than fourfold over the past 40 years to more than 460 million people today

all-cause mortality rates have declined substantially in several high-income countries, including england. a diversification in non-fatal conditions in people with dm has also been reported. this is attributable to broader, non-vascular conditions. due to increasing longevity among people with type 2 dm with increasing and diversifying multimorbidity in them, the health needs of people with type 2 dm are therefore likely to be broad, and complex. finding multimorbidity (two or more chronic conditions) is common in people with type 2 dm and increasing, but the comorbidity profiles of people with t2dm vary substantially. many studies have primarily focused on identifying multimorbidity patterns in the general population. the understanding of multimorbidity patterns and composition of specific comorbidities in people with dm, and how this varies across patient groups and during the course of the disease, is limited. further knowledge of this could provide insight into providing more holistic and more personal approaches to clinical guideline development, care pathways, and secondary prevention.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes. exclusion criteria: 1. patients with type 1 diabetes. 2. patients with secondary diabetes.
early debridement within 24 hours after surgery for wound healing of abdominal incision

Conditions: Surgical Wound

Summary: wound healing after surgery is a complex procedure. liquefaction of the fat and necrosis of inactivated tissue, as well as blood clots are always accumulated mostly within 24 hours after surgery. as such, early debridement within 24 hours after surgery might improve the healing of the wounds. this study is designed to compare the impact of early debridement of the wound versus regular dressing (24 hours later) on the wound healing. 100 patients will be included in this study, and divided into 2 groups randomly. then, the healing of the wound, stitch removal time, incidence of incision complications will be compared between the two groups.


Eligibility criteria:
inclusion criteria: * the patient with major abdominal incision. exclusion criteria: * pregnant woman * patient with diabetes * patient with a history of cardiovascular disease, including coronary heart disease and stroke. * severe lung diseases such as copd and asthma * patients undergoing emergent surgery or infectious surgery * patients with surgical site infection or abdominal abscess * no autonomy, inability or unwillingness to participate in follow-up

Keywords: surgical wound suture, complication
anaplastic lymphoma kinase (alk)-positive non-small cell lung cancer (nsclc) post-alectinib treatment patterns

Conditions: Non-Small-Cell Lung Carcinoma

Summary: this study aims to understand patient profiles, treatment patterns, and clinical outcomes among alk-positive nsclc patients treated with alectinib, and post-alectinib treatment patterns and outcomes.


Eligibility criteria:
inclusion criteria: 1. patients with a documented diagnosis of nsclc. 2. patients ≥ 18 years of age at initial recorded diagnosis of nsclc. 3. patients who received treatment with alectinib during the study identification period, including those who initiated alectinib prior (index date-1) to the start of the study identification period. 4. during the study observation period, patients observed with at least 2 visits after the index date-1. exclusion criteria: 1. receipt of treatment indicated for another primary cancer or diagnosis of another primary cancer (with the exception of non-melanotic skin cancer), within 5 years of index date-1 will be excluded. 2. patients enrolled in clinical trials prior to receiving alectinib during the study id period (index date-1), will be included and flagged in the analysis.
study to evaluate the long-term safety and tolerability of usl261 in patients with seizure clusters

Conditions: Epilepsy

Summary: the purpose of this study is to examine the long-term safety and tolerability of usl261 in the treatment of seizure clusters.

participants who completed study p261-401 (nct01390220), a randomized double-blind study of usl261 (intranasal midazolam) versus placebo to acutely treat a seizure cluster episode, were eligible to to enroll in this open-label extension study (p261-402). the participant's caregiver administered a usl261 5 milligram (mg) dose for a seizure episode meeting study criteria. a second usl261 5 mg dose could be administered after 10 minutes and up to 6 hours after the first dose for persistent or recurrent seizures, unless the participant met exclusions to administration of the second dose. a participant could have more than 1 seizure cluster episode treated during his/her study participation.

Eligibility criteria:
inclusion criteria: * has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes * has successfully completed study p261-401, and the subject and caregiver have demonstrated adequate compliance with p261-401 study procedures as determined by the investigator exclusion criteria: * has experienced status epilepticus during or since the p261-401 study * in the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from p261-401 at visit 1 or did experience a clinically significant adverse event in study p261-401 that might prevent the subject from safely participating in the study * has a neurological disorder that is likely to progress in the next year * has a history of acute narrow-angle glaucoma * has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy * subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen * has had psychogenic, non-epileptic seizure(s) during or since the p261-401 study * has active suicidal plan or intent as determined by the c-ssrs at visit 1 or medical history * subject has had vagus nerve stimulator (vns) implanted since the completion of study p261-401

Keywords: epilepsy seizure clusters acute repetitive seizures rescue treatment
efficacy of tavns versus sham stimulation in reduing depressive symptoms in patients with epilepsy: a multi-center, double-blinded, randomized, 20-week, parallel-arm, superiority study

Conditions: Depressive Symptoms in Patients With Epilepsy

Summary: the purpose of this study is to compare the efficacy of tavns versus sham stimulation in reduing depressive symptoms in patients with epilepsy.


Eligibility criteria:
inclusion criteria: * adults age ≥18 * confirmed diagnosis of epilepsy (based on 2014 definition by ilae) * having comorbidity with mild-moderate depression (confirmed diagnosis by a psychiatrist) * willing and able to provide informed conset exclusion criteria: * those experiencing status epilepticus or frequent seizures requiring emergency medication within the year prior to recruitment * those with severe depression or anxiety who are in urgent need of psychiatric care * those who are imminently suicidal or unable to keep themselves safe * those experiencing severe cognitive difficulties with day-to-day memory, attention, and ability to learn basic information * those having a pacemaker, a invasive vagus nerve stimulator, or a metal implant * the pinna is not suitable for earplugs * pregnancy

Keywords: transcutaneous auricular vagus nerve stimulation epilepsy depression
clinical application of 18f-labeled rd2 pet/ct imaging in the diagnosis and treatment of small liver carcinoma

Conditions: Liver Carcinoma

Summary: this is a single arm study to evaluate the safety and biodistribution of 18f-labeled rd2 pet/ct imaging in patients with small liver carcinoma.


Eligibility criteria:
inclusion criteria: 1. patients with highly suspected tumor； 2. patients underwent pet/ct examination within 1 week; 3. patients voluntarily signed informed consent; 4. over 18 years old, male or female. exclusion criteria: 1. pregnant women; 2. lactating women; 3. patients with impaired renal function.
study of mdx-1411 given every 14 days with pre-medications to subjects with clear cell kidney cancer.

Conditions: Kidney Cancer

Summary: to determine the highest and safest tolerated dose of mdx-1411 for the treatment of clear cell renal cell carcinoma (kidney cancer).

subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. the maximum duration for the study is two and a half years for a total of 17 cycles.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of rcc with clear cell component * measurable disease * treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy * subjects with treated brain metastases must be without magnetic resonance imaging (mri) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible * at least 28 days since the last chemotherapy * at least 28 days before the first dose of mdx 1411 since any major surgery * ecog performance status 0-2 * no known positivity for human immunodeficiency virus (hiv), hep b or c exclusion criteria: * previous treatment with any other anti-cd70 antibody * active infection requiring i.v systemic therapy within 28 days before first dose * evidence of bleeding diathesis or coagulopathy * active autoimmune disease requiring immunosuppressive therapy * known current drug or alcohol abuse * any underlying medical condition which will make the administration of mdx 1411 hazardous * psychiatric illness or social situation that would preclude study compliance

Keywords: medarex inc.
study evaluating eaa-090 in adult outpatients with neuropathic pain associated with diabetic neuropathy

Conditions: Diabetes Mellitus; Diabetic Neuropathy, Painful

Summary: eaa-090 is being developed for the treatment of neuropathic pain associated with diabetic neuropathy. it is a selective antagonist that binds competitively to the glutamate site of the n-methyl-d-aspartate (nmda) receptor. this study will assess the safety and efficacy of 3 fixed oral doses of eaa-090 compared with placebo in subjects with neuropathic pain associated with diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * women of childbearing potential must have a negative serum pregnancy test result at screening * diabetes mellitus (type i or ii) that is controlled by oral or parenteral hypoglycemic agents or diet * diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy exclusion criteria: * pregnancy, lactation, or plans to become pregnant during the study * depo-provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control * history of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator

Keywords: neuropathic pain diabetic neuropathy
treatment of patients with advanced pancreatic cancer after gemcitabine failure.

Conditions: Pancreatic Adenocarcinoma Advanced or Metastatic

Summary: in brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. for locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.there is no standard treatment regimen for second-line, however paclitaxel demonstrated effect on second-line phase ii study. metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. there is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (igf-1). this study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in icesp previously treated with gemcitabine. the objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.


Eligibility criteria:
inclusion criteria: * pancreatic advanced or metastatic adenocarcinoma histologically confirmed. * previously treatment with gemcitabine as adjuvant or metastatic disease. * clinical or radiological evidence of disease progression, determined by physician. is not mandatory recist (response evaluation criteria in solid tumors) evaluation to determine the progression of disease before the study inclusion. * patient with intolerance to gemcitabine, even without disease progression, are also eligible. * eastern cooperative oncology group (ecog) performance status 0 - 2 * at least 10 weeks of life expectation. * adequate organ function defined as: * serum ast (aspartate aminotransferase) and alt (alanine aminotransferase)≤ 2.5 × uln (upper normal limit) * total bilirubin ≤ 2,0 x uln * absolute neutrophil count ≥ 1,500/ mm3 * platelets ≥100.000/ mm3 * hemoglobin ≥ 8,0 g/dl * serum creatinine ≤ 1,5 uln and clearance of creatinine estimated (cockcroft- gault) ≥ 50 ml/min * signed written informed consent. exclusion criteria: * major surgical procedure within 4 weeks of the beginning of the treatment. * history of serious clinical or psychiatric disease. * symptomatic hypoglycemia at the screening visit. * target lesion radiotherapy within 4 weeks of the beginning of the treatment. * treatment with any anti-cancer investigational drug. * treatment with any igf-i or igfr-i * treatment with metformin within 12 months prior to commencing study treatment * for female patients, current pregnancy and/or lactation
study on prediction of fluid responsiveness using an abdominal compression-induced change of blood pressure in children

Conditions: Hypovolemia

Summary: the purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children.

the purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children. when there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmhg, right upper abdomen is gently compressed for 10 seconds. changes of blood pressure are continuously recorded during this period. about 3 min later, intravenous colloid fluid 10 ml/kg is infused for 20 min. to evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. in addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration. finally, patients will be divided into fluid responder group and non-responder group. if cardiac output measured using echocardiography increases over 15% after fluid administration, the patient is fluid responder. using roc curve, diagnostic power of abdominal compression-induced blood pressure change for fluid responsiveness will be evaluated.

Eligibility criteria:
inclusion criteria: * pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery exclusion criteria: * renal, hepatic and pulmonary disease * preoperative infection: increased cpr, wbc over 10,000, and with fever * genetic and hematologic disease * intracardiac and extracardiac shunt * single ventricle * right heart dysfunction * any intracardiac valve pathology * increased intracranial pressure